Articulable anchor

ABSTRACT

Embodiments disclosed herein relate to devices implantable into a human lung, for example to reduce the volume of air trapped in a diseased portion of the lung to prevent inhalation while permitting expiration out of the diseased portion. In some embodiments, the device comprises a distal portion with an anchor system that may anchor the device into tissue of an air passageway wall, and the distal portion may be connected to a proximal portion via a flexible portion that permits the distal portion to articulate substantially with respect to the proximal portion, such that the distal portion and the proximal portion may be non-collinear along a longitudinal axis of the distal portion. This may facilitate implantation of the device into a non-linear air passageway.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/457,346, filed Apr. 26, 2012, which is a continuation of U.S.application Ser. No. 12/754,394, filed Apr. 5, 2010, now issued as U.S.Pat. No. 8,454,708, which is a continuation of U.S. application Ser. No.11/585,415, filed Oct. 24, 2006, now issued as U.S. Pat. No. 7,691,151,which claims the benefit under 35 U.S.C. 119(c) to U.S. ProvisionalPatent Application No. 60/787,995, filed Mar. 31, 2006. The foregoingapplications are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The inventions relate in general to the field of pulmonary treatments,and specifically to systems, devices, and methods for treating apatient's lung or portion thereof.

2. Description of the Related Art

Chronic Obstructive Pulmonary Disease (“COPD”) has become a major causeof morbidity and mortality in the United States. COPD is typicallycharacterized by the presence of airflow obstructions due to chronicbronchitis or emphysema. The airflow obstructions in COPD are duelargely to structural abnormalities in the smaller airways in the lungs.

Mortality, health-related costs, and the segment of the populationhaving adverse effects due to COPD are substantial. COPD is aprogressive disease that can severely affect a person's ability toaccomplish normal tasks. One method of treating COPD is the insertion ofone-way valves into lumens in the lung. The valves inhibit inhalation,but permit exhalation of air already within the lung. The lung presentschallenge in mounting such valves because lumens within it are rarelylinear over a useful distance. Accordingly, there is a need for a deviceto permit mounting of valves within non-linear lumens in the lung.

SUMMARY OF THE INVENTION

Accordingly, one aspect of the invention comprises an implantable devicefor providing substantially one-way flow of air through a lumen in ahuman lung to reduce the volume of air trapped in a diseased portion ofthe lung. The implantable device occludes the lumen to substantiallyprevent inhalation while substantially permitting expiration out of saiddiseased portion of the lung. The implantable device is deployable intothe lumen with a catheter.

One aspect of an embodiment of the implantable device can comprise aone-way valve being generally umbrella-shaped in configuration. Thevalve is collapsible for containment within a delivery catheter andexpandable in situ when deployed. The valve substantially occludes thelumen. The valve is configured so that when deployed in an orientationto substantially preclude inhalation, inhaled air is prevented fromflowing past the valve into said lung by capturing said air within theumbrella-shaped valve. The air exerts an outward force on the umbrellashape and forces said valve to tightly engage the lumen. The valve isconfigured to permit expiration to occur between the perimeter of thevalve and the lumen.

The valve also defines a longitudinal axis and comprises a plurality ofmetal struts that define a generally bell-shaped frame. Each of thestruts have a first end that curves slightly inward towards thelongitudinal axis of said implantable device when deployed and a secondend proximal a junction of the second ends of the other struts, Thevalve also has a resilient membrane that wraps around at least a part ofthe metal struts and is supported by them. The membrane extends from thejunction of the plurality of metal struts toward the first end of saidstruts. The valve also comprises a central post with a first part thatextends within the membrane from the junction of said plurality of metalstruts at the center of the bell-shaped frame. The post has a flange atan end distal from the strut junction. The flange is configured topermit deployment, positioning, and recapture of said implantabledevice. The central post further comprises a second part that extendsaxially outside the membrane.

Another aspect of the invention comprises an anchor for securing theimplantable device within the lumen by inhibiting migration of thedevice once deployed. The anchor comprises a plurality of resilient armsextending outwardly and radially from the second part of the centralpost. Each of said arms are configured so as to be collapsible forcontainment within a delivery catheter and expandable to engage thelumen when deployed in situ. Each of the arms comprises a generallytapered distal end to permit the arm to penetrate the wall of the lumen.The arms further comprise a planar member proximal the tapered distalend and positioned at an angle to the arm to limit advancement of saidarm into the lumen wall by contacting the surface of said lumen wall.

Another aspect of the invention comprises a mechanism connecting theone-way valve to the anchor and being disposed generally along thelongitudinal axis when the device is in a collapsed state. The mechanismis configured to permit the valve to be oriented at an angle to theanchor when deployed, thereby allowing the anchor to be positioned in asection of the lumen that is at an angle to a section of said lumen inwhich the one-way valve is positioned. The mechanism comprises at leastone connector at a first end to connect the mechanism to the valve. Insome embodiments, the mechanism comprises a flexible member configuredto be articulable to permit angled orientation of the anchor. In someembodiments, the flexible member comprises a helical spring. In someembodiments, the flexible member comprises a generally cylindrical mesh.

In some embodiments of the connector, a second end of the mechanismcomprises a generally spherical connector. In some embodiments, thesecond end of the mechanism resides in a cavity within the anchor. Insome embodiments the cavity is elongated. In some embodiments, the firstend of the mechanism comprises a generally spherical connector.

In some embodiments, a cavity is within the anchor, wherein the firstend of the mechanism can reside. In some embodiments, the implantabledevice comprises a second end of the mechanism which comprises agenerally spherical connector. In some embodiments, the second end ofthe mechanism resides in a cavity within the valve. In some embodiments,at least one of the cavities is elongated.

Another aspect of an embodiment is an implantable device for deploymentin an anatomical lumen wherein the device comprises an occluding deviceand an articulable anchor for securing the occluding device within thelumen in a manner that permits the anchor to articulate substantiallywith respect to said occluding device. The articulable anchor comprisesa mechanism connecting said anchor to the occluding device.Additionally, the mechanism comprises at least one connector at a firstend to connect said mechanism to at least one anchoring member and thearticulable anchor includes a cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an implantable device with a one-wayvalve, an anchor, and a connector;

FIG. 2 is a side view of an implantable device with an articulableanchor.

FIG. 3 is a cross-sectional view of the device of FIG. 2.

FIG. 4 is a cross-sectional view of an air passageway and an implantabledevice with an articulable anchor that spans a bifurcated airpassageway;

FIG. 5 is a cross-sectional view of an implantable device with anarticulable anchor in accordance with another embodiment;

FIG. 6 is a cross-sectional view of an implantable device with anarticulable anchor in accordance with another embodiment;

FIG. 7 is a side view of an implantable device with an articulableanchor in accordance with another embodiment;

FIG. 8 is a side view of a flexible connector for use in an implantabledevice with an articulable anchor;

FIG. 9 is a side view of an implantable device with an articulableanchor having a biasing member and a connector positioned between anobstruction member and the anchor system;

FIGS. 10A-10C are side views of alternative embodiments of frames forimplantable devices with articulable members embodied as flexibleconnectors; and

FIG. 11 is a cross-sectional view of an air passageway and a flexibleimplantable device positioned in the air passageway

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates an implantable device in an expanded position. Theimplantable device 10 is configured to affect airflow in an airpassageway in a lung. The implantable device comprises an anchor 12 andan obstruction member 14. A connecting mechanism 16 couples the anchor12 to the obstruction member 14. The illustrated implantable device 10includes a support structure 18 that can form the frame of theimplantable device 10. At least a portion of the anchor 12, theconnecting mechanism 16, and the obstruction member 14 can be formed bythe support structure 18. An elongated member 20 extends axially throughobstruction member 14 and can be directly or indirectly coupled to thesupport structure 18.

The obstruction member 14 surrounds at least a portion of the elongatedmember 20 and is configured to interact with an anatomical lumen, suchas an air passageway, to regulate the flow of fluid through the lumen.The obstruction member 14 can effectively function as a one-way valve.One example of an obstruction member is an occluding device.

The anchor 12 comprises a plurality of anchor members 22 that extendfrom the connecting mechanism 16. In the illustrated embodiment, each ofthe anchor members 22 is an elongated member that extends radiallyoutward from the connecting mechanism 16 and terminates at a piercingend 24, although the anchor members 22 can have any number of piercingends. One or more stops 26 can be positioned along each anchor member22, preferably positioned at some point near the piercing members 24.The stops 26 can be configured to limit the puncturing by the piercingmember 24 through lung tissue beyond a desired depth.

The stops 26 can be formed by splitting the distal ends of the anchormembers 22. One of the split sections can be bent downwardly to form thestop 26, while leaving the second split section to extend outwardly toform the piercing member 24. Although the stops 26 can be formedintegrally with the anchor member 22, the stops 26 can also be appliedin a subsequent process. For example, each stop 26 can be a piece ofmetal that is mounted to the anchor members 22. Thus, each of the anchormembers 22 can be of a one piece or multi-piece construction.

Any number of anchor members 22 can be used to limit migration of theimplantable device 10 implanted at a desired deployment site. Theillustrated implantable device 10 comprises five anchor members 22 thatare coupled to the connecting mechanism 16. However, the anchor 12 cancomprise any suitable number of anchor members in any variousconfigurations. A skilled artisan can select the number of anchormembers 22 based on the size of an air passageway, anchor design, andthe like. The anchor members 22 can be positioned at regular orirregular intervals. When the anchor 12 is positioned in situ, thepiercing members 24 can engage tissue of an air passageway wall of alung to retain the implantable device 10 at a desired location. Onenon-limiting example of such an engagement occurs when at least onepiercing member punctures the wall of the air passageway.

With continued reference to FIG. 1, the obstruction member 14 isgenerally umbrella-shaped and comprises an obstructing member frame 28that carries a membrane 32. The obstructing frame 28 includes aplurality of arcuate struts 30 that support the membrane 32.

A plurality of pathways can be defined by the obstruction member 14between each pair of struts 30. When the implantable device 10 issecurely anchored in a lung passageway, the struts 30 can bias theobstruction member 14 outwardly against the air passageway wall. Betweeneach pair of struts 30, the membrane 32 can define the pathway thatpermits mucus transport past the obstruction member 14 through theassociated air passageway.

Proper mucociliary functioning can be maintained to ensure that therespiratory system continues to self clean after an implantable devicehas been deployed. To maintain mucociliary transport the membrane 32 canbe folded inwardly away from the air passageway wall, especially duringexhalation when the implantable device 10 has the anchor 12 positioneddistally. The membrane 32 can press lightly against the air passagewaywall in order to permit cilliary action for the movement of mucus pastthe membrane 32. Of course, the implantable device can have otherconfigurations that permit mucus transport.

The membrane 32 can be treated to enhance sealing, improve biostability,and/or enhance mucus transport. To enhance valving action, the membrane32 can be treated with a material that interacts with a wall of an airpassageway to improve functioning. A coating on the membrane can reduceairflow in at least one direction between the air passageway and theexpanded membrane engaging the air passageway wall. The coating can be ahydrogel that helps the membrane 32 adhere to the air passageway wall tofurther limit air flow past the implantable device in at least onedirection. Other coating materials can be applied to the membrane orother portions of the implantable device depending on the intendedapplication. The coating can be applied before, during, or after theimplantable device is placed in a passageway.

In some embodiments, the membrane 32 can be coated with a lubriciousmaterial to limit adherence to an air passageway. Additionally, animplantable device may partially or fully collapse when subjected torapid pressure changes, such as when a person coughs. If the membrane isfolded together, the lubricious material can inhibit sticking of themembrane to itself so that the implantable device can quickly re-expandto function effectively again.

The implantable device can be adapted to facilitated movement through adelivery lumen. To reduce frictional forces between the implantabledevice and a lumen of a delivery instrument, a release agent can beapplied to the implantable device. The release agent can reduce theforce required to eject the implantable device out of the lumen asdetailed above.

The struts can have first strut ends connected to the connectingmechanism 16 and opposing second strut ends. The proximal tips of thestruts can curve radially inward toward the longitudinal axis of theimplantable device 10.

With continued reference to FIG. 1, the elongated member 20 comprises arod 34 that is connected to the connecting mechanism 16 and a grippinghead 36. The rod 34 is a generally cylindrical body that extends alongthe longitudinal axis of the implantable device 10, although the rod 34can be at other suitable locations. For example, the rod 34 can beangled or offset from the longitudinal axial of the implantable device10.

The rod 34 is connected to the gripping head 36 that is positionedexterior to the chamber defined by the membrane 32. The rod 34 extendsfrom the opening such that the gripping head 36 is spaced outwardly fromthe opening defined by the membrane 32. The elongated member 20 can beof such a length that it extends beyond the second end of the strutswhen the implantable 10 occupies an expanded position. When the grippinghead 36 is spaced from the proximal ends of the struts and the membrane32, a removal device (not shown) can easily grip the exposed grippinghead 36. In alternative embodiments, the rod 34 terminates to form thegripping head 36 positioned inwardly of the opening defined by themember 32. Other embodiments of the gripping head 36 can include variouschanges in shape and size of the gripping head 36 to cooperate withdifferent coupling mechanisms.

The elongated member 20 can also be of such a length that the elongatedmember 20 and the struts 30 extend substantially the same distance fromthe connecting mechanism 16 when the implantable device 10 is in a fullycollapsed state (not shown). The struts 30 can lie flat along the rod 34for a low profile configuration. The gripping head 36 preferably remainsexposed so that the implantable device 10 can be pushed out of adelivery instrument by conveniently applying a force to the grippinghead 36.

A variety of removal devices can be used to engage the implantabledevice to, for example, reposition, re-implant, or remove theimplantable device as discussed above. The enlarged gripping head 36 canbe designed to facilitate removal of the implantable device 10 by any ofnumerous extracting devices and methods as are known in the art. Theremoval gripping head 36 can be gripped by a removal device (such asforceps, an extractor, a retractor, gripping device, or other suitabledevice for gripping a portion of the implantable device 10). Asufficient proximal force can be applied to displace the implantedimplantable device 10 from the implantation site. The illustratedgripping head 36 is a somewhat cylindrical knob having an outer diameterthat is greater than the outer diameter of the rod 34. The gripping head36 can have other configurations for engaging a removal device.Exemplary gripping heads can comprise a hook, ring, enlarged portion,connectors (e.g., snap connector, threaded connector, etc), or otherstructure for permanently or temporarily coupling to a removal device.

FIG. 2 is a side view of an embodiment of an implantable device 50. Theobstruction member 58 is coupled with the anchor 56 by a connectingmechanism 52. In the illustrated embodiment, the connecting mechanism 52comprises a connecting member 54. The connecting mechanism 52 permitsarticulation between the obstruction member 58 and the anchor 56. In theillustrated position, the obstruction member 58 and the anchor 56 arecollinear along the longitudinal axis of the implantable device 50.Through articulation of the connecting mechanism 52, the obstructionmember 58 and the anchor 56 can be configured to no longer be collinearalong the longitudinal axis of the implantable device 50. As onenon-limiting example, the obstruction member 58 can be maintained at anunaltered orientation while the connecting mechanism 52, either bypivoting or flexing, can continue to couple the obstruction member 58 tothe anchor 56 while the anchor 56 is moved to a different orientationthan that of the obstruction member 58. In some embodiments, theconnecting mechanism 52 can permit axial movement, changing the distancebetween the distal end of the obstruction member 58 and the proximal endof the anchor 56. In some embodiments, the articulation of theconnecting mechanism 52 is accomplished through discrete pivotalorientation changes. In other embodiments, the connecting mechanism 52is configured to articulate through continuous flexing, such as thebending of a flexible member. In still other embodiments, the connectingmechanism 52 can be configured to permit changes in orientation betweenthe obstruction member 58 and the anchor 56 by limiting separationbetween the obstruction member 58 and the anchor 56 when the connectingmechanism 52 is not rigidly coupled to the two components. In theseembodiments, the connecting mechanism 52 can comprise a tether or otherlimiting component.

FIG. 3 is a cross-sectional view of another embodiment of an implantabledevice 100. The implantable device 100 is configured to permit an angledposition. The implantable device 100 can be positioned in a naturallyangled air passageway (e.g., a bifurcated air passageway, tortuous airpassageway, etc.) in a lung. The implantable device 100 has an anchorsufficiently articulable so as to permit deployment of the implantabledevice 100 within the angled air passageway without substantiallyaltering the natural geometry of the air passageway. The implantabledevice 100 can effectively function even though the obstructing member102 conforms to the natural shape of the air passageway. The implantabledevice 100 can be generally similar to the implantable device 10 of FIG.1, and accordingly, the following description of the implantable device100 can equally apply to the implantable devices described below, unlessindicated otherwise.

As used herein, the term “implantable device” is a broad term and isused in its ordinary meaning and includes, without limitation,articulated implantable devices, actuatable implantable devices, andother implantable devices that have one or more means for providingarticulation, actuating, or flexibility between an anchor and afunctional member, such as an obstruction member. The implantabledevices may have any number of pivot points or flexible portions. Theseimplantable devices can be placed along tortuous pathways, such as asection of a lung passageway that is substantially curved along itslength. Some embodiments include a means for providing flexibility thatcomprises any combination of a biasing member, a flexible member, a balland socket arrangement, a joint, a linkage, a hinge, and/or a flexibleconnector. As such, the flexible implantable device can be selectivelycurved or angled along its length to match the shape of the airpassageway.

The illustrated implantable device 100 comprises an obstructing member102 articulably and pivotally connected to an anchor system 104. Theanchor system 104 can be moved relative to the obstructing member 102 toa desired position depending on the functional application of the device100. An articulating connecting portion 106 connects and permitsmovement between the obstructing member 102 and the anchor system 104.The articulating connecting portion 106 permits articulation of thedevice 100 such that the device 100 can be implanted in curved airpassageways without significantly altering the natural geometry of theair passageway. For example, the implantable device 100 can span abronchial branching section of a lung. The implantable device 100 can bearticulated repeatedly (e.g., during normal lung functioning) withoutappreciable trauma to the lung, or to the implantable device 100.Traditional stent-based devices for implantation in air passageways aretypically rigid elongated structures that are not suitable for placementin bifurcated or substantially curved air passageways. These stent-baseddevices maintain their linear configuration thus rendering themunsuitable for use in these types of air passageways.

With reference again to FIG. 3, the articulating connecting portion 106can have various configurations for permitting relative movement betweenthe anchor system 104 and the obstructing member 102. In someembodiments, including the illustrated embodiment, the articulatingconnecting portion 106 comprises at least one ball and socketarrangement. The illustrated anchor system 104 has an anchor socket 120comprising a generally spherical cavity that holds one end of theconnecting rod 124, while the obstructing member 102 has an obstructingsocket 122 that holds the other end of the connecting rod 124.

The connecting rod 124 has a first end 128 and an opposing second end126. Each of the ends 126, 128 is generally spheroidal and sized to bereceived by the corresponding socket 122, 120. The spheroidal shape theends 126, 128 can be integral with the connecting rod 124 or generallyspheroidal-shaped members can be coupled to or mounted on the ends 126,128. The first end 128 is rotatably mounted in the obstructing socket122. The second end 126 is rotatably mounted in the anchor socket 120.As such, the sockets 120, 122 can rotate freely about the ends of theconnecting rod 124. Thus, the implantable device 100 has a plurality ofjoints that permit articulation. The implantable device can have anynumber of articulable connecting portions for a particular application.

To reduce wear of the balls and the sockets, the surface(s) of thesockets and/or ends 126, 128 can be coated with a material to reducefrictional interaction. For example, the interior surface 130 of theanchor socket 120 can comprise one or more of the following: a somewhatlubricious material (e.g., Teflon®), ceramics, metals, polymers(preferably hard polymers), or combinations thereof. However, othermaterials can be utilized to limit or inhibit wear between theconnecting rod 124 and the obstructing member 102 and/or the anchorsystem 104. When the implantable device 100 is deployed in the lungs,the anchor socket 120 can move, preferably slightly, with respect to theball at the second end 126 during normal respiration. The wear-resistantsurfaces can minimize debris build up that can impede performance of theimplantable device 100. In view of the present disclosure, one ofordinary skill in the art can determine the appropriate combination ofmaterials, geometry of the ball and socket arrangement, and the lengthof the connecting rod 124 to achieve the desired positioning of theimplantable device 100.

The connecting rod 124 can have a one-piece or multi-piece construction.In some embodiments, the connecting rod body 142 and the ends 126, 128are formed of a single material (e.g., a metal such as Nitinol ortitanium). In other embodiments, the connecting rod body 142 is formedof a flexible material, and the ends 126, 128 are formed of a somewhathard, rigid material, such as a ceramic.

The connecting rod 124 can be generally straight, as shown in FIG. 3.However, the connecting rod 124 can have other configurations based onclinical need. For example, the connecting rod 124 of FIG. 8 has anangled shape that allows placement of the implantable device in acomplex shaped airway (e.g., an airway with sharp curves, branchingportions, etc.).

With continued reference to FIG. 3, an elongated member 134 includes arod 138 having an end portion 140 that is connected to the obstructingmember frame 136. The end portion 140 can be connected to the frame 136by one or more mechanical fasteners, adhesives, welding, boarding,interference fit, threads, or other suitable coupling means for securelycoupling the rod 138 to the frame 136. In some embodiments, includingthe illustrated embodiment, the rod 138 is connected to the interiorportions of the struts 110, although the rod can be connected to otherportions of the frame 136. The rod 138 can also be formed integrallywith at least a part of the frame.

As shown in FIG. 4, the implantable device 150 can be placed at abranching air passageway of the bronchial tree. The obstructing member152 is within a proximal passageway 160 and the anchor system 154 ispositioned within a distal sub-branch air passageway 162. Theimplantable device 150 can therefore span the junction 164 of the airpassageway of the lung and, thus, permits flexibility in positioning ofthe device 150. The air passageway can generally retain its naturalshape, such as its shape before implantation of the implantable device150, to minimize trauma to the lung tissue. The orientations of theimplantable devices are not limited solely to the illustratedorientations. The implantable device 150 can be reversed from theillustrated orientation so that the anchors are located proximally ofthe obstruction member. Thus, the implantable device 150 can be orientedto permit air flow in any desired direction.

The implantable device 150 can also be implanted in non-branchingportions of lungs. If desired, the implantable device 150 can beimplanted in continuous air passageways that are generally straight,curved, angled, or having any other configuration. Because theimplantable device 150 can assume various configurations, there issignificant flexibility in selecting a deployment site. The implantabledevice 150 can also be implanted in air passageways that have asubstantially constant or varying cross-section. Advantageously, thephysician can implant the implantable device 150 at various locationsthroughout the lung to treat specific portions of the lung. If theimplantable devices are in the form of occluding devices or flowregulating devices (e.g., a one-way valve, flow resistor, etc.), thesedevices can be implanted proximally of, and adjacent to, the diseasedportions of a lung, thus maximizing the amount of healthy lung tissuethat can function, even if the diseased lung tissue is in the far distalportions of the bronchial tree.

FIG. 5 illustrates an implantable device 200 that comprises an anchorsystem 202 that is pivotally coupled to an elongated member 204 thatextends through the obstructing member 206. The elongated member 204 hasa generally spheroidal member 208 that is rotatably mounted in an anchorsocket 210 of the anchor system 202. The obstructing member 206 can befixedly attached at some point along the elongated member 204.

To secure the obstructing member 206 to the elongated member 204, aportion of an obstructing member frame 212 and/or a membrane 214 can becoupled to the elongated member 204. In the illustrated embodiment, thestruts of the obstructing member frame 212 and the membrane 214 are bothcoupled to the outer surface of the elongated member 204.

Once deployed, the implantable device 200 illustrated in FIG. 5 can beretained in place by the anchor system 202. The implantable device 200can be positioned in a non-linear lumen, such as those illustrated inFIG. 4, because the anchor system 202 may remain at a first orientationwhile the obstructing member 206 is pivoted to a second orientation bythe generally spheroidal member 208 and the anchor socket 210. Theobstructing member 206 can be configured to move axially from the anchorsystem 202 through travel along the elongated member 204, which can belimited to prevent inefficient operation of the implantable device 200.

FIG. 6 is a cross-sectional view of a implantable device 250 that has anarticulable connecting portion 252 that permits axial movement betweenan anchor system 254 and an obstructing member 256. The connectingportion 252 includes a holder 260 of the anchor system 254 and a holder262 of the obstruction member 256. Each of the holders 260, 262 isconfigured to receive an end of a connector 264. The illustratedconnector 264 has enlarged ends that are held by the holders 260, 262.The chambers 268, 278 of the holders 260, 262, respectively, permitaxial movement of the connector 264. The enlarged ends of the connector264 that are held by the holders 260, 262 can also be constructed topermit pivotal movement in addition to axial movement.

The anchor system 254 and the obstructing member 256 of the device 250can move freely towards and away from each other. However, one or morebiasing members (not shown) can be positioned between the anchor systemand obstructing member of the implantable device to adjust positioningof the implantable device. The biasing member can cooperate with theconnecting portion to ensure that the implantable device remains in adesired position.

FIG. 7 illustrates an implantable device 300 that has an articulatingconnecting portion 302 that includes a flexible member 304 connected tothe anchor system 306 and the obstructing member 308. The flexiblemember 304 can comprise a somewhat flexible elongated member (e.g., asolid rod, a hollow tube, ribbon, etc.) and can comprise metal, polymers(preferably a somewhat rigid polymer), filaments, and the like. Theflexible member 304 preferably does not substantially stretch or bucklewhen an axial force is applied thereto. Alternatively, the flexiblemember 304 can be configured to allow significant axial movement betweenthe anchor system 306 and the obstructing member 308. The flexiblemember 304 can be, for example, a tether that holds together and limitsthe axial movement of the anchor system 306 away from the obstructingmember 308. However, the flexible member 304 may be easily collapsed asthe anchor system 306 is moved towards the obstructing member 308. Theflexible member 304 can comprise a rope, wire, filaments, or othersuitable member for providing relative movement between the anchorsystem 306 and the obstructing member 308.

With reference to FIG. 8, the connecting rod 350 can have or bend tohave an angled central portion 352 that defines an angle θ. The lengthL1 and L2 can be selected to achieve the desired orientation and size ofan implantable device. If the implantable device is deployed at a sharpbend of an air passageway, the angle θ can be matched with the angle ofthe bend to generally align the longitudinal axis of an anchor systemwith one of the passages and the longitudinal axis of an obstructingmember with the other passage. The implantable device, for example, caninclude a connecting rod for deployment in air passageways that togetherform an acute angle. Accordingly, the configuration of the connectingrod 350 can be selected based on the target deployment site.

As illustrated in FIG. 9, the implantable device 400 can have a biasingmember 402 positioned between an obstructing member 404 and an anchorsystem 406. One example of such a biasing member is a helical spring. Inthe illustrated embodiment, a tether 408 extends through the biasingmember 402 between the obstructing member 404 and the anchor system 406.Other embodiments can have a tether 408 connecting the obstructingmember 404 and an anchor system 406 that does not extend through thebiasing member 402 and instead passes at least partially outside thebiasing member 402. Alternatively, a flexible cylindrical member (notshown) can extend between the obstructing member 404 and the anchorsystem 406, substantially completely enclosing the biasing member 402.The tether can also be a connector such as the one illustrated in FIG.7.

FIGS. 10A-10C illustrate various embodiments of support frames ofimplantable devices, each having a means for flexing. Each of thesupport frames has a flexible connecting portion that permits relativemovement between an anchor system and an obstructing member frame. Theframes as illustrated do not have membranes; however, any of varioustypes of membranes can be applied to the obstructing member frames. FIG.10A illustrates a frame support 450A that includes a flexible connectingportion 452A in the form of slots in an alternating pattern. Theconnecting portion 452A can be an integral piece with the frame, asillustrated, or can be coupled or mounted to an anchor system 454A andan obstruction frame 456A. The flexible connecting portion 452A can beformed by cutting slots out of a tube. The number and size of the slotscan be selected to achieve the desired flexibility. Additionally, thematerial used to construct the connecting portion can be selected forits flexibility characteristics.

FIG. 10B illustrates a frame support 500B that is generally similar tothe frame support 450A of FIG. 10A. In the illustrated embodiment, theframe support 500B includes a flexible connecting portion 502B in theform of a spring member extending axially along the longitudinal axis ofthe frame support 500B. As such, the spring member can be arranged in aspiral fashion about the longitudinal axis of the flexible connectingportion 502B. The illustrated spring member is in the form of a helicalspring, although other types of springs or resilient members can beutilized. The spring can comprise the connecting member alone or can actas a biasing member, as described above. Additionally, as describedabove, the spring can be formed integrally with the frame, or serve as acoupler for both an anchor system and obstruction frame.

FIG. 10C illustrates a frame support 550C that comprises a flexibleconnecting portion 552C comprising a mesh. The connecting portion 552Ccan comprise a mesh of various sizes, with large or small mesh spaces.Additionally, the mesh can be constructed of a variety of materials,such as metals, synthetics, or any other resilient material. The meshcan permit flexing, as when the obstructing frame 554C and anchor system556C are positioned at different orientations, as described above. Insome embodiments, the mesh can also permit axial compression along thelongitudinal axis of the frame support 550C. As described, the mesh canbe formed integrally with the frame, or be mounted or coupled at eitherend to the obstructing frame 554C and anchor system 556C.

The illustrated struts 600A, 600B, 600C of FIGS. 10A-10C each have twogenerally elongated straight portions connected by a bend. The struts600A, 600B, 600C can also have a continuously curved configurationsimilar to the struts described above. The frame supports can carry amembrane to form an obstructing member, such as an obstructing memberadapted to function as a valve (preferably a one-way valve). Theconnecting portions can enhance the seating of the obstructing memberwithin an air passageway to enhance valve functioning.

With reference to FIG. 11, an implantable device 700 is illustrated ashaving a flexible connecting portion 702, such as the one shown in FIG.10A. The implantable device 700 is deployed and implanted in an airpassageway 708 and is held in place by its anchor system 704. Theflexible connecting position 702 can apply a force to the obstructingmember 706 of the implantable device 700 to enhance seating between themembrane of the obstructing member 706 and the wall 708. Thus, a bias ofthe flexible connecting portion 702 can ensure that an effective seal ismaintained between the obstructing member 706 and the wall 708, therebylimiting or preventing the flow of air distally past the implantabledevice 700. Advantageously, the implantable device 700 can permit thepassage of air proximally past the obstructing member 706 when thepressure differential across the implantable device 700 is sufficientlyhigh. As the air flows proximally past the obstructing member 706, theflexible connecting portion 702 can apply a distally directed force.When the pressure differential is reduced a sufficient amount, theobstructing member 706 is pulled distally against the air passagewaywall 708 to once again form a seal with the air passageway wall. Thus,the obstructing member 706 can move slightly during normal lungfunctioning while the anchor system 704 can remain securely fixed inplace. The flexible connecting portion 702 can therefore enhance thevalving action of the implantable device 700.

If desired, the connecting portion 702 can also be used to position theanchors 704 and the obstructing member 706 along a tortuous path withina lung, as shown in FIG. 4 above. The connecting portion 702 can bepositioned along sharp turns that may be unsuitable for rigid valves,such as stent-based devices.

All patents and publications mentioned herein are hereby incorporated byreference in their entireties. Except as further described herein, theembodiments, features, systems, devices, materials, methods andtechniques described herein may, in some embodiments, be similar to anyone or more of the embodiments, features, systems, devices, materials,methods and techniques described in U.S. patent application Ser. Nos.10/409,785 (U.S. Publication 2004-0200484), filed Apr. 8, 2003;09/951,105 (U.S. Publication No. 2003/0050648A1), filed Mar. 13, 2003;10/848,571, filed May 17, 2004; 10/847,554, filed May 17, 2004;10/418,929, filed Apr. 17, 2003; 10/081,712 (U.S. Publication2002-0112729), filed Feb. 21, 2002; 10/178,073 (U.S. Publication2003-0154988), filed Jun. 21, 2002; 10/317,667 (U.S. Publication2003-0158515), filed Dec. 11, 2002; 10/103,487 (U.S. Publication2003-0181922), filed Mar. 20, 2002; 10/124,790 (U.S. Publication2003-0195385), filed Apr. 16, 2002; 10/143,353 (U.S. Publication2003-0212412), filed Mar. 9, 2002; 10/150,547 (U.S. Publication2003/0216769), filed May 17, 2002; 10/196,513 (U.S. Publication2004-0010209), filed Jul. 15, 2002; 10/254,392 (U.S. Publication2004//0059263), filed Sep. 24, 2002; 10/387,963 (U.S. Publication2004-0210248), filed Mar. 12, 2003; 10/745,401, filed Dec. 22, 2003;U.S. Pat. Nos. 6,293,951; 6,258,100; 6722360; 6,592,594, which arehereby incorporated herein and made part of this specification. Inaddition, the embodiments, features, systems, devices, materials,methods and techniques described herein may, in certain embodiments, beapplied to or used in connection with any one or more of theembodiments, features, systems, devices, materials, methods andtechniques disclosed in the above-mentioned incorporated applicationsand patents.

The articles disclosed herein may be formed through any suitable means.The various methods and techniques described above provide a number ofways to carry out the invention. Of course, it is to be understood thatnot necessarily all objectives or advantages described may be achievedin accordance with any particular embodiment described herein. Thus, forexample, those skilled in the art will recognize that the methods may beperformed in a manner that achieves or optimizes one advantage or groupof advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments disclosed herein.Similarly, the various features and steps discussed above, as well asother known equivalents for each such feature or step, can be mixed andmatched by one of ordinary skill in this art to perform methods inaccordance with principles described herein. Additionally, the methodswhich are described and illustrated herein are not limited to the exactsequence of acts described, nor are they necessarily limited to thepractice of all of the acts set forth. Other sequences of events oracts, or less than all of the events, or simultaneous occurrence of theevents, may be utilized in practicing the embodiments of the invention.

Although the invention has been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that the invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. Accordingly, the invention is notintended to be limited by the specific disclosures of preferredembodiments herein.

What is claimed is:
 1. An implantable device configured to be securedwithin an air passageway, the device comprising: a distal portioncomprising an anchor system and a longitudinal axis, the anchor systemcomprising at least one piercing tip and being configured to engagetissue of an air passageway wall; a proximal portion; and a flexibleportion connecting the distal portion to the proximal portion, theflexible portion being configured such that the distal portion canarticulate substantially with respect to the proximal portion such thatthe distal portion and the proximal portion are non-collinear along thelongitudinal axis of the distal portion.